SETROF TABLET 50MG [SIN14221P]

Product Info

SETROF TABLET 50MG

[SIN14221P]

INDICATIONS

Sertraline is indicated for the treatment of:

1. symptoms of depression, including depression accompanied by symptoms of anxiety, in patients with or without a history of mania. Following satisfactory response, continuation with sertraline therapy is effective in preventing relapse of the initial episode of depression or recurrence of further depressive episodes.

2. obsessive compulsive disorder (OCD). Following initial response, sertraline has been associated with sustained efficacy, safety and tolerability in up to 2 years of treatment of OCD.

3. panic disorder, with or without agoraphobia.

4. post-traumatic stress disorder (PTSD).

5. social phobia (social anxiety disorder).

6. premenstrual dysphoric disorder (PMDD).

DOSAGE AND ADMINISTRATION

Sertraline should be administered once daily, either in the morning or evening. Sertraline tablets can be administered with or without food.

Initial Treatment
Depression and OCD:
Sertraline treatment should be administered at a dose of 50 mg/day.

Panic Disorder, PTSD & Social Phobia:
Therapy should be initiated at 25 mg/day. After one week, the dose should be increased to 50 mg once daily. This dosage regimen has been shown to reduce the frequency of early treatment emergent side effects characteristic of panic disorder.

Premenstrual Dysphoric Disorder:
Sertraline treatment should be initiated with a dose of 50mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.

Titration
Depression, OCD, Panic Disorder and PTSD:
Patients not responding to a 50 mg dose may benefit from dose increases. Dose changes should be made at intervals of at least one week, up to a maximum of 200 mg/day. Changes in dose should not be made more frequently than once per week given the 24 hour elimination half life of sertraline.

The onset of therapeutic effect may be seen within 7 days. However, longer periods are usually necessary to demonstrate therapeutic response, especially in OCD.

Premenstrual Dysphoric Disorder:
Patients not responding to a 50 mg/day dose may benefit from dose increases (at 50 mg increments/menstrual cycle) up to 150 mg/day when dosing daily throughout the menstrual cycle, or 100 mg/day when dosing during the luteal phase of the menstrual cycle. If a 100 mg/day dose has been established with luteal phase dosing, a 50 mg/day titration step for three days should be utilized at the beginning of each luteal phase dosing period.

Maintenance:
Dosage during long-term therapy should be kept at the lowest effective level, with subsequent adjustment depending on therapeutic response.

Use in the Elderly:
The same dose range as in younger patients may be used in the elderly.

Use in Hepatic Insufficiency:
The use of sertraline in patients with hepatic disease should be approached with caution. A lower or less frequent dose should be used in patients with hepatic impairment.

Use in Renal Insufficiency:
Sertraline is extensively metabolized. Excretion of unchanged drug in urine is a minor route of elimination. As expected from the low renal excretion of sertraline, sertraline dosing does not have to be adjusted based on the degree of renal impairment.

Note: The information given here is limited. For further information, consult your doctor or pharmacist.

CONTRAINDICATIONS

• Contraindicated in patients with a known hypersensitivity to sertraline.

• Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated.

• Concomitant use in patients taking pimozide is contraindicated.